Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213383
Company: DR REDDYS
Company: DR REDDYS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DASATINIB | DASATINIB | 20MG | TABLET;ORAL | Prescription | AB | No | No |
| DASATINIB | DASATINIB | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| DASATINIB | DASATINIB | 70MG | TABLET;ORAL | Prescription | AB | No | No |
| DASATINIB | DASATINIB | 80MG | TABLET;ORAL | Prescription | AB | No | No |
| DASATINIB | DASATINIB | 100MG | TABLET;ORAL | Prescription | AB | No | No |
| DASATINIB | DASATINIB | 140MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/03/2025 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213383Orig1s000TAltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/30/2025 | SUPPL-2 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
DASATINIB
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DASATINIB | DASATINIB | 20MG | TABLET;ORAL | Prescription | No | AB | 216261 | ALEMBIC |
| DASATINIB | DASATINIB | 20MG | TABLET;ORAL | Prescription | No | AB | 202103 | APOTEX |
| DASATINIB | DASATINIB | 20MG | TABLET;ORAL | Prescription | No | AB | 217217 | BIOCON PHARMA |
| DASATINIB | DASATINIB | 20MG | TABLET;ORAL | Prescription | No | AB | 213383 | DR REDDYS |
| DASATINIB | DASATINIB | 20MG | TABLET;ORAL | Prescription | No | AB | 216547 | EUGIA PHARMA |
| DASATINIB | DASATINIB | 20MG | TABLET;ORAL | Prescription | No | AB | 214350 | LUPIN |
| DASATINIB | DASATINIB | 20MG | TABLET;ORAL | Prescription | No | AB | 211094 | TEVA PHARMS USA |
| DASATINIB | DASATINIB | 20MG | TABLET;ORAL | Prescription | No | AB | 218719 | ZYDUS PHARMS |
| SPRYCEL | DASATINIB | 20MG | TABLET;ORAL | Prescription | Yes | AB | 021986 | BRISTOL MYERS SQUIBB |
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DASATINIB | DASATINIB | 50MG | TABLET;ORAL | Prescription | No | AB | 216261 | ALEMBIC |
| DASATINIB | DASATINIB | 50MG | TABLET;ORAL | Prescription | No | AB | 202103 | APOTEX |
| DASATINIB | DASATINIB | 50MG | TABLET;ORAL | Prescription | No | AB | 217217 | BIOCON PHARMA |
| DASATINIB | DASATINIB | 50MG | TABLET;ORAL | Prescription | No | AB | 213383 | DR REDDYS |
| DASATINIB | DASATINIB | 50MG | TABLET;ORAL | Prescription | No | AB | 216547 | EUGIA PHARMA |
| DASATINIB | DASATINIB | 50MG | TABLET;ORAL | Prescription | No | AB | 214350 | LUPIN |
| DASATINIB | DASATINIB | 50MG | TABLET;ORAL | Prescription | No | AB | 211094 | TEVA PHARMS USA |
| DASATINIB | DASATINIB | 50MG | TABLET;ORAL | Prescription | No | AB | 218719 | ZYDUS PHARMS |
| SPRYCEL | DASATINIB | 50MG | TABLET;ORAL | Prescription | Yes | AB | 021986 | BRISTOL MYERS SQUIBB |
TABLET;ORAL; 70MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DASATINIB | DASATINIB | 70MG | TABLET;ORAL | Prescription | No | AB | 216261 | ALEMBIC |
| DASATINIB | DASATINIB | 70MG | TABLET;ORAL | Prescription | No | AB | 202103 | APOTEX |
| DASATINIB | DASATINIB | 70MG | TABLET;ORAL | Prescription | No | AB | 217217 | BIOCON PHARMA |
| DASATINIB | DASATINIB | 70MG | TABLET;ORAL | Prescription | No | AB | 213383 | DR REDDYS |
| DASATINIB | DASATINIB | 70MG | TABLET;ORAL | Prescription | No | AB | 216547 | EUGIA PHARMA |
| DASATINIB | DASATINIB | 70MG | TABLET;ORAL | Prescription | No | AB | 214350 | LUPIN |
| DASATINIB | DASATINIB | 70MG | TABLET;ORAL | Prescription | No | AB | 211094 | TEVA PHARMS USA |
| DASATINIB | DASATINIB | 70MG | TABLET;ORAL | Prescription | No | AB | 218719 | ZYDUS PHARMS |
| SPRYCEL | DASATINIB | 70MG | TABLET;ORAL | Prescription | Yes | AB | 021986 | BRISTOL MYERS SQUIBB |
TABLET;ORAL; 80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DASATINIB | DASATINIB | 80MG | TABLET;ORAL | Prescription | No | AB | 216261 | ALEMBIC |
| DASATINIB | DASATINIB | 80MG | TABLET;ORAL | Prescription | No | AB | 203180 | APOTEX |
| DASATINIB | DASATINIB | 80MG | TABLET;ORAL | Prescription | No | AB | 217217 | BIOCON PHARMA |
| DASATINIB | DASATINIB | 80MG | TABLET;ORAL | Prescription | No | AB | 213383 | DR REDDYS |
| DASATINIB | DASATINIB | 80MG | TABLET;ORAL | Prescription | No | AB | 216547 | EUGIA PHARMA |
| DASATINIB | DASATINIB | 80MG | TABLET;ORAL | Prescription | No | AB | 214350 | LUPIN |
| DASATINIB | DASATINIB | 80MG | TABLET;ORAL | Prescription | No | AB | 211094 | TEVA PHARMS USA |
| DASATINIB | DASATINIB | 80MG | TABLET;ORAL | Prescription | No | AB | 218719 | ZYDUS PHARMS |
| SPRYCEL | DASATINIB | 80MG | TABLET;ORAL | Prescription | Yes | AB | 021986 | BRISTOL MYERS SQUIBB |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DASATINIB | DASATINIB | 100MG | TABLET;ORAL | Prescription | No | AB | 216261 | ALEMBIC |
| DASATINIB | DASATINIB | 100MG | TABLET;ORAL | Prescription | No | AB | 202103 | APOTEX |
| DASATINIB | DASATINIB | 100MG | TABLET;ORAL | Prescription | No | AB | 217217 | BIOCON PHARMA |
| DASATINIB | DASATINIB | 100MG | TABLET;ORAL | Prescription | No | AB | 213383 | DR REDDYS |
| DASATINIB | DASATINIB | 100MG | TABLET;ORAL | Prescription | No | AB | 216547 | EUGIA PHARMA |
| DASATINIB | DASATINIB | 100MG | TABLET;ORAL | Prescription | No | AB | 214350 | LUPIN |
| DASATINIB | DASATINIB | 100MG | TABLET;ORAL | Prescription | No | AB | 211094 | TEVA PHARMS USA |
| DASATINIB | DASATINIB | 100MG | TABLET;ORAL | Prescription | No | AB | 218719 | ZYDUS PHARMS |
| SPRYCEL | DASATINIB | 100MG | TABLET;ORAL | Prescription | Yes | AB | 021986 | BRISTOL MYERS SQUIBB |
TABLET;ORAL; 140MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DASATINIB | DASATINIB | 140MG | TABLET;ORAL | Prescription | No | AB | 216261 | ALEMBIC |
| DASATINIB | DASATINIB | 140MG | TABLET;ORAL | Prescription | No | AB | 203180 | APOTEX |
| DASATINIB | DASATINIB | 140MG | TABLET;ORAL | Prescription | No | AB | 217217 | BIOCON PHARMA |
| DASATINIB | DASATINIB | 140MG | TABLET;ORAL | Prescription | No | AB | 213383 | DR REDDYS |
| DASATINIB | DASATINIB | 140MG | TABLET;ORAL | Prescription | No | AB | 216547 | EUGIA PHARMA |
| DASATINIB | DASATINIB | 140MG | TABLET;ORAL | Prescription | No | AB | 214350 | LUPIN |
| DASATINIB | DASATINIB | 140MG | TABLET;ORAL | Prescription | No | AB | 211094 | TEVA PHARMS USA |
| DASATINIB | DASATINIB | 140MG | TABLET;ORAL | Prescription | No | AB | 218719 | ZYDUS PHARMS |
| SPRYCEL | DASATINIB | 140MG | TABLET;ORAL | Prescription | Yes | AB | 021986 | BRISTOL MYERS SQUIBB |